510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982211Substantially Equivalent

Profile-II Model 600582

MEDTOX Diagnostics, Inc., Burlington NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982211 is the FDA 510(k) clearance record for PROFILE-II MODEL 600582, a class II device, cleared for Medtox Diagnostics, Inc. on under FDA product code DKE (Reagents, Test, Tetrahydrocannabinol). FDA records list 22 510(k) clearances for Medtox Diagnostics, Inc., from to . As of , FDA records show no recalls naming K982211.

Clearance record

Decision date
Received
(36 days to decision)
Product code
DKE Reagents, Test, Tetrahydrocannabinol
Regulation
21 CFR 862.3870
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Medtox Diagnostics, Inc. 1238 Anthony Rd., Burlington NC
510(k) summary
Statement
Third party review
No

Clearances, product code DKE

Trailing 12 months

FDA records hold no clearances under product code DKE in the trailing twelve months.

FDA records show no clearances under product code DKE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DKE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260